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Fluid Management in Patients Undergoing Cardiac Surgery

NCT ID: NCT02895659

Last Updated: 2017-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-01

Study Completion Date

2017-10-19

Brief Summary

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Background: Currently used crystalloid solutes have a variable composition and may therefore influence acid-base status, intra- and extracellular water content and plasma electrolyte compositions and have a major impact on organ function and outcome. Despite continuing evaluation no superiority of one particular type of fluid has been reached so far. To the best of the investigators' knowledge no study in humans has ever assessed whether the type of crystalloid fluid given for fluid resuscitation in patients undergoing cardiac surgery has an impact on hemodynamic stability and cardiac function so far. Nonetheless in the animal model it was shown that the choice of crystalloid fluid may greatly influence cardiac performance

Primary Aim: In this study the investigators want to clarify whether a balanced type acetate-buffered fluid solution in patients undergoing cardiac surgery is associated with better hemodynamic stability and cardiac function than a lactate-buffered crystalloid solute.

Detailed Description

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Conditions

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Critical Illness

Keywords

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fluid management critical illness hemodynamics buffered infusates

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ringer lactate

Fluid resuscitation will be performed with lactated Ringers during the perioperative period. Perioperative hemodynamic management will be performed according to a specified treatment protocol.

Group Type ACTIVE_COMPARATOR

perioperative hemodynamic management with vasoactive medications (norepinephrine, adrenaline ect)

Intervention Type PROCEDURE

Perioperative hemodynamic management will be performed according to a specified treatment protocol.

Ringer acetate

Fluid resuscitation will be performed with acetated Ringers during the perioperative period. Perioperative hemodynamic management will be performed according to a specified treatment protocol.

Group Type ACTIVE_COMPARATOR

perioperative hemodynamic management with vasoactive medications (norepinephrine, adrenaline ect)

Intervention Type PROCEDURE

Perioperative hemodynamic management will be performed according to a specified treatment protocol.

Interventions

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perioperative hemodynamic management with vasoactive medications (norepinephrine, adrenaline ect)

Perioperative hemodynamic management will be performed according to a specified treatment protocol.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Elective single heart valve replacement
* Elective double valve replacement
* Elective single or double valve replacement and coronary artery bypass grafting

Exclusion Criteria

* Patients unable to give informed consent
* Patients younger than 18 years of age or older than 80 years
* Pregnancy or breastfeeding
* Ejection fraction (EF) of less than 30% preoperatively
* Preexisting renal insufficiency with a glomerular filtration rate below 30ml/min
* Patients transferred form the intensive care unit to the operating theater
* Emergency operation
* Reoperation
* Patients planned for fast-track surgery
* Patients planned for minimal extracorporal circuits
* Preexisting anemia requiring immediate perioperative blood transfusion
* Chronic inflammatory diseases
* Any signs of infection or sepsis
* Limitation of full therapy (e.g. Jehowa's witnesses)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carmen A Pfortmueller, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Intensive Care, Bern University Hospital and University of Bern, Bern, Switzerland

Locations

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Department of Intensive Care, Bern University Hospital and University of Bern, Bern, Switzerland

Bern, , Switzerland

Site Status

Countries

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Switzerland

References

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Pfortmueller CA, Faeh L, Muller M, Eberle B, Jenni H, Zante B, Prazak J, Englberger L, Takala J, Jakob SM. Fluid management in patients undergoing cardiac surgery: effects of an acetate- versus lactate-buffered balanced infusion solution on hemodynamic stability (HEMACETAT). Crit Care. 2019 May 6;23(1):159. doi: 10.1186/s13054-019-2423-8.

Reference Type DERIVED
PMID: 31060591 (View on PubMed)

Other Identifiers

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20160804.1.3

Identifier Type: -

Identifier Source: org_study_id